Events

Retiro De Equipo (Recall) de Akron Tilt Table couches

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Arjo Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2018-RN-00605-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00605-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a complaint related to akron tilt table middle section frame breakage. the investigation showed that one of the critical welds was missing. not all devices are affected by this defect, however, this issue is seen as a potential hazard and arjo australia seeks to prevent the possibility of any related event occurring again.There was no injury related to this incident.
  • Acción
    ArjoHuntleigh is requesting customers: Complete and sign the Customer Response Form supplied with the customer letter and return this form to the local ArjoHuntleigh office as per the directions given. An ArjoHuntleigh Service person will contact the person you listed on the Customer Response Form to schedule service to verify and (if needed) rework your device, free of charge.

Device

Akron Tilt Table couches
  • Modelo / Serial
    Akron Tilt Table couchesSerial Numbers: P0167499 and P0418644Model Numbers: A8652 and A8652TProduct Codes: A8652 and A8652TARTG Number: 288419(Arjo Australia Pty Ltd - Table, examination/treatment)
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA